DNA Bioscience

David Davies: To ask the Minister of State, Department for Constitutional Affairs 
	(1)  if she will take steps to ascertain the nature and level of the ISO certification of  (a) DNA Diagnostic and  (b) DNA Bioscience as providers of services to her Department;
	(2)  what representations have been received by the Department on the performance of DNA Bioscience; and if she will make a statement;
	(3)  what investigations have been initiated by the Department into DNA Bioscience.

Bridget Prentice: I refer the hon. Member for Monmouth to my reply on 24 October 2005,  Official Report, column 8W. I am still investigating the matters raised in the hon. Member's questions, and I will write when I am in a position to do so.
	 Substantive answer from Ms Harman to David T.C. Davies:
	 Parliamentary Questions - Accredited list of paternity testers
	You tabled a number of questions relating to the list maintained by the Department for Constitutional Affairs of bodies which may carry out court directed scientific tests for parentage (numbers 20036, 20110, 20111, 20120 to 20125, 20883, 21275, 21276, 21598 to 21601, 22730 22744, and 22745. The answers are contained in a paper that has been placed in the libraries of both Houses today. I enclose a copy.
	 Accreditation of Paternity Testing Bodies by the Department for Constitutional Affairs
	 Introduction
	This paper covers the ground raised in Parliamentary Questions (numbers 20036, 20110, 20111, 20120 to 20125, 20883, 21275, 21276, 21598 to 21601, 22730, 22744, 22745 and 25226) tabled in the Commons toward the end of last year.
	The Department for Constitutional Affairs maintains a list of bodies accredited by it to carry out scientific tests for parentage (nowadays usually DNA tests) under section 20 of the Family Law Reform Act 1969. This list is for use by the civil courts in England and Wales where the court makes a direction under section 20 of the 1969 Act.
	"Section 20 directions" are not given in every civil case where parentage is an issue. Where parties submit DNA evidence by agreement and without any section 20 direction being given, it is not essential for the testing body to be chosen from the accredited list. As with other evidence, it is for the court to consider questions of admissibility and weight of the evidence.
	 Background to the accredited list
	The Family Law Reform Act 1969 made provision for court-directed blood testing to determine paternity. The provisions were amended in the Child Support Pensions and Social Security Act 2000, to refer to "scientific tests" (reflecting the development of DNA technology which could be applied to bodily samples other than blood). References to "paternity" were replaced with "parentage" so as to be gender-neutral.
	Section 20 of the Family Law Reform Act 1969 provides that in any civil proceedings a court may give a direction for the use of scientific tests to ascertain whether such tests show that a party to the proceedings is or is not the father or mother of a person whose parentage falls to be determined. By virtue of subsection (1A), tests may only be carried out by a body which has been accredited for the purposes of section 20 by the Lord Chancellor, or a body appointed by him for the purpose. Section 20(2) of the 1969 Act provides that the individual carrying out court-directed scientific tests must report to the court stating the results, whether a person is excluded from parentage and (if not) the value of the results in determining parentage. The report is to be received as evidence of the matters stated. It must be in a prescribed form (subsection (3)). Any party may seek a written explanation or amplification, which is deemed to be part of the report (subsection (4)). A party must serve notice of an intention to call the tester within 14 days of receiving the report. It is expressly provided that where the tester is called as a witness the party is entitled to cross-examine him (subsection (5)).
	Section 22 provides that the Lord Chancellor may make regulations about "section 20 directions" and may prescribe conditions for eligibility for accreditation (subsection (1)(f)). The regulations are the Blood Tests (Evidence of Paternity) Regulations 1971, as amended (including to reflect the 2000 Act).
	 The Blood Tests (Evidence of Paternity) Regulations 1971, as amended
	These Regulations set out the detailed changes that made it possible for bodily samples other than blood to be taken, and for scientific tests to be used to establish whether a person is a natural parent of the person whose parentage is to be determined. The Regulations also provided that the tests were to be carried out by an accredited body (rather than an individual, which was the case under the previous scheme).
	Regulation 8A provides that a body shall not be eligible for accreditation for the purposes of section 20 of the 1969 Act unless it is accredited to ISO/IEC/17025 by an accreditation body which complies with the requirements of ISO Guide 58 (now replaced by ISO 17011).
	The Regulations also deal with the procedures for taking bodily samples, despatch to a tester, testing and then reporting to the court. The Regulations require the completion of 2 statutory forms. Form 1 is called a "Direction Form" and is to be filled in by the court, the sampler and the tester. Form 2 is called "Report by Tester" and is to be filled in by the tester. All of this is designed to ensure that the right people actually provide samples, that the same samples reach the tester, and that the nominated tester does the testing and reports to the court.
	 Criteria for DCA accreditation prior to the recent review
	The ISO accreditation is a statutory requirement for "section 20" accreditation by the Department, as set out above. Bodies wishing to be added to the Department's accredited list were expected to produce evidence (either an original or a certified copy) of a valid and current ISO/IEC/17025 accreditation certificate, given by an accreditation body that complies with ISO/IEC Guide 58 (now ISO 17011).
	A further non-statutory requirement was added, as a matter of policy. This was a requirement to give an undertaking to comply with the Department of Health's  Code of Practice and Guidance on Genetic Paternity Testing Services. This Code sets out best practice and clear standards for organisations delivering paternity testing services generally.
	These criteria were put in place in 2001, when the Blood Tests (Evidence of Paternity) (Amendment) Regulations 2001 (SI 2001 No. 773) came into effect.
	More recent practice has been to require that written applications be made to be added to the DCA accredited list.
	The particular International Standards Organisation (ISO) standards were chosen because they were considered to be the most appropriate standards for this area of activity. ISO/IEC/17025 is an accreditation given to testing and calibration laboratories that meet certain competence requirements. There was no formal or public consultation on the criteria chosen for accreditation, but the 2001 Regulations, as a statutory instrument, had the approval of Parliament. The Department of Health's Code was put together by an ad-hoc advisory group on genetic paternity testing services, whose membership included service providers, clinicians, academics and scientists.
	 Ensuring compliance with ISO/IEC 17025 standards
	The accreditation bodies ensure compliance with ISO/IEC 17025 by undertaking regular reviews and re-accreditations. Because accreditation bodies are the technical experts, it is not necessary or appropriate for representatives of the Department themselves to visit any of the DCA-accredited laboratories, and no-one from the Department has ever done so. For the purposes of DCA accreditation, if an up to date and valid ISO 17025 certificate is produced (an original or certified copy) and the accreditation body is ISO Guide 58 (now ISIO 17011) compliant, then this is proof enough of the laboratory's competence.
	Bodies accredited by DCA are not permitted to contract out parentage tests directed by the court under s20 to any other organisation.
	 How the courts ensure accredited bodies carry out parentage tests where a section 20 direction is given
	Where the court is considering an application for a paternity test in the course of civil proceedings, and the parties do not agree to the testing, then section 20 of the 1969 Act is available. The court may give a formal direction (on Form 1, a statutory form, part of the Blood Tests (Evidence of Paternity) Regulations 1971 (as amended)) which will include the name and address of the body that is to carry out the test. The body will be chosen from the list of accredited bodies. The tester (a person employed to carry out scientific tests by an accredited laboratory) will complete and sign Form 2, (the Report by the Tester) to certify the result of the test. As explained above, the Regulations, which include the two statutory forms, are designed to ensure the authenticity and integrity of the samples, and that the nominated tester carries out and reports on the test.
	The list the Department maintains relates only to bodies which may carry out court-directed scientific tests for parentage in accordance with a direction made by a court pursuant to section 20 of the Family Law Act 1969. Where the court has not directed the test, parties to a case may submit DNA evidence by agreement and in accordance with case management directions of the court. It is not essential for the testing body to be chosen from the accredited list. As with other evidence, it is for the court to consider questions of admissibility and weight.
	 The investigation
	Starting in October last year, a number of Questions were tabled in Parliament and the Department received a number of press enquires about DNA Bioscience and the accredited list generally. This prompted an investigation as to the eligibility of each of the bodies on the accredited list, and the work also extended to a review of the processes and procedures associated with adding bodies to the list and the maintenance of it.
	The review did not extend to any examination of the financial accounts of the bodies on the DCA accredited list. DCA has no responsibility in this area. The bodies on the accredited list do not provide services to the Department. The accredited list simply exists to provide the civil courts with the names of bodies that reach a certain standard for use when the court directs a test under section 20 of the Family Law Reform Act 1969.
	The courts dealing with civil proceedings (including family proceedings) were informed about the review, and of the details of the laboratories to which referrals for court-directed tests should be made until the accredited list was re-issued. The laboratories concerned had provided the Department with up to date evidence they had the requisite ISO/IEC 17025 accreditation and with up to date undertakings that they complied with the Department of Health's Code.
	The Department undertook to remove ineligible bodies from the accredited list. There were six bodies that were found to be ineligible, including DNA Diagnostics Center and DNA Bioscience, three public sector laboratories (one of which no longer carries out paternity testing) and one body, not itself a testing body, which works in conjunction with another public sector laboratory. These bodies can no longer carry out section 20 tests and the civil courts have been informed. However, the Department has found no evidence that any individual or organisation has supplied misleading or incorrect information during the accreditation process and so further action taken against any individual or company would not be appropriate.
	 DNA Diagnostics Center and DNA Bioscience
	DNA Bioscience was not, itself, accredited by the DCA to carry out court-directed tests under s20. It was not a testing facility, so had no ISO 17025 accreditation and therefore was not eligible. Following an application from DNA Bioscience, DCA agreed in October 2005 that DNA Diagnostics Center (the laboratory DNA Bioscience used to conduct DNA tests) could be added to the accredited list. DNA Diagnostics Center is a US laboratory with ISO/IEC/17025 accreditation, accredited by Forensic Quality Services - a US accreditation body. DNA Diagnostics Center was shown on the accredited list with a Chelmsford address then belonging to DNA Bioscience. The Department was aware that DNA Bioscience was acting as an intermediary for DNA Diagnostics Center.
	The Department agreed orally in December 2004 that DNA Bioscience's details could be added to the accredited list, but DNA Bioscience did not make an application to be added to the accredited list on its own account. The intention was to add those details as a referral route to the accredited body (DNA Diagnostics Center).
	The Department is not aware of anything to suggest that reliable evidence was not produced for the courts in relation to court-directed tests.
	No DCA Minister, current or past, has had any communication, conversation, or correspondence with David Blunkett about DNA Bioscience.
	 Applications turned down and laboratories closed down
	From the Departmental records available, it appears that one application was received in 2003 from a laboratory that had no ISO 17025 accreditation. The laboratory in question indicated that they intended to apply for ISO 17025 accreditation, but nothing further was heard from them.
	Nothing has been found in the Department's records that are now available to indicate that any laboratory accredited by DCA to carry our court-directed parentage tests has closed down in the past five years.
	 Bodies currently accredited
	The following laboratories, all based in the UK, have submitted evidence of valid and up to date accreditation to the relevant ISO standard. They have recently given signed undertakings to comply with revised criteria (see "New criteria"). They were all bodies on the previous list.
	Cellmark Diagnostics (now Orchid Cellmark),
	Crucial Genetics,
	LGC Diagnostics, and
	The Forensic Science Service
	No laboratories outside the UK are currently accredited, but there is no statutory bar on the accreditation of overseas laboratories. The Department will continue to consider application from laboratories, wherever situated (see "New criteria" below).
	 New criteria and policy
	As a result of the review, the Department will now require applications to be made on a form prescribed by it, signed and submitted in hard copy.
	As before, bodies wishing to be added to the accredited list must have a current and valid ISO/IEC 17025 certificate that has been issued by an accreditation body which complies with ISO/IEC 17011 (formerly ISO Guide 58) An original certificate or a certified copy must be submitted with the application form. There is a new requirement that the accreditation body must also be a full member of the International Laboratory Accreditation Cooperation (ILAC). The Department considers that this is needed to demonstrate independent evidence of ISO/IES 17011 compliance. The United Kingdom Accreditation Service (UKAS) is the UK body that complies with this new requirement.
	Bodies wishing to be added to the accredited list must undertake to comply with the Code of Practice and Guidance on Genetic Paternity Testing Services, published by the Department of Health, or any revised version thereof.
	With regard to the Code, although the undertaking applies to parentage tests directed by the court pursuant to s20 of the Family Law Reform Act 1969, the Government strongly encourages providers of genetic paternity testing services to adhere to the Code for all tests. Applicants will be made aware of that view and will be informed that when section 45 of the Human Tissue Act comes into force later this year, it will be a criminal offence to take DNA, with the intention of having it tested, without consent.
	Bodies wishing to be added to the accredited list must undertake to comply, or ensure compliance with, the procedures as set out in the Blood Test (Evidence of Paternity) Regulations 1971 (SI 1971/1861) (as amended).
	Bodies wishing to be added to the accredited list must undertake to limit any statement regarding DCA accredited status on any promotional material, advertising, or web-site information to the following:
	"[Name of Organisation] has been accredited by the Department for Constitutional Affairs as a body that may carry out parentage tests directed by the civil courts in England and Wales under section 20 of the Family Law Reform Act 1969".
	Applicants will be advised that the Department regards phrases such as 'Government approved', 'Lord Chancellor approved' or 'DCA approved' as misleading and therefore not acceptable.
	All organisations on the DCA accredited list will be expected to be subject to an annual review to confirm eligibility, including compliance with the accreditation criteria to remain on the list. This will include giving renewed undertakings as set out above and ensuring compliance with any revised criteria.
	In future, the Department will not accept applications from intermediaries. The Department will continue to consider applications from laboratories outside the UK, but if any should meet the (revised) criteria and are added to the list, they will be shown with their overseas addresses and other contact details. If an overseas laboratory makes an application proposing to use an intermediary in the UK, the laboratory will be asked to explain how its proposed use of an intermediary would conform with the relevant legislation (The Blood Tests (Evidence of Paternity) Regulations 1971 (as amended)).
	This information and guidance will be published on the Department's web-site.
	 Applications pending
	The Department currently has seven applications or enquiries about how to apply which the Department will now pursue and consider against the revised list of criteria. A revised list will then be issued.

DNA Bioscience

David Laws: To ask the Minister of State, Department for Constitutional Affairs whether DNA Bioscience is accredited for DNA-related work in the UK.

Bridget Prentice: I refer the hon. Member to my reply to the hon. Member for Monmouth (David T.C. Davies) on 24 October 2005,  Official Report, column 8W. I am still investigating the matters raised by the hon. Member's question, and I will write when I am in a position to do so.
	 Substantive answer from Ms Harman to Mr. Laws:
	 Parliamentary Question - Accredited list of paternity testers
	You tabled a question asking whether DNA Bioscience is accredited for DNA-related work in the UK (number 25226). The answer is contained in the paper, covering a number of issues on the accreditation of DNA paternity testers, which has been placed in the Libraries of both Houses today. I enclose a copy.
	 Accreditation of Paternity Testing Bodies by the Department for Constitutional Affairs
	 Introduction
	This paper covers the ground raised in Parliamentary Questions (numbers 20036, 20110, 20111, 20120 to 20125, 20883, 21275, 21276, 21598 to 21601, 22730, 22744, 22745 and 25226) tabled in the Commons toward the end of last year.
	The Department for Constitutional Affairs maintains a list of bodies accredited by it to carry out scientific tests for parentage (nowadays usually DNA tests) under section 20 of the Family Law Reform Act 1969. This list is for use by the civil courts in England and Wales where the court makes a direction under section 20 of the 1969 Act.
	"Section 20 directions" are not given in every civil case where parentage is an issue. Where parties submit DNA evidence by agreement and without any section 20 direction being given, it is not essential for the testing body to be chosen from the accredited list. As with other evidence, it is for the court to consider questions of admissibility and weight of the evidence.
	 Background to the accredited list
	The Family Law Reform Act 1969 made provision for court-directed blood testing to determine paternity. The provisions were amended in the Child Support Pensions and Social Security Act 2000, to refer to "scientific tests" (reflecting the development of DNA technology which could be applied to bodily samples other than blood). References to "paternity" were replaced with "parentage" so as to be gender-neutral.
	Section 20 of the Family Law Reform Act 1969 provides that in any civil proceedings a court may give a direction for the use of scientific tests to ascertain whether such tests show that a party to the proceedings is or is not the father or mother of a person whose parentage falls to be determined. By virtue of subsection (1A), tests may only be carried out by a body which has been accredited for the purposes of section 20 by the Lord Chancellor, or a body appointed by him for the purpose. Section 20(2) of the 1969 Act provides that the individual carrying out court-directed scientific tests must report to the court stating the results, whether a person is excluded from parentage and (if not) the value of the results in determining parentage. The report is to be received as evidence of the matters stated. It must be in a prescribed form (subsection (3)). Any party may seek a written explanation or amplification, which is deemed to be part of the report (subsection (4)). A party must serve notice of an intention to call the tester within 14 days of receiving the report. It is expressly provided that where the tester is called as a witness the party is entitled to cross-examine him (subsection (5)).
	Section 22 provides that the Lord Chancellor may make regulations about "section 20 directions" and may prescribe conditions for eligibility for accreditation (subsection (1)(f)). The regulations are the Blood Tests (Evidence of Paternity) Regulations 1971, as amended (including to reflect the 2000 Act).
	 The Blood Tests (Evidence of Paternity) Regulations 1971, as amended
	These Regulations set out the detailed changes that made it possible for bodily samples other than blood to be taken, and for scientific tests to be used to establish whether a person is a natural parent of the person whose parentage is to be determined. The Regulations also provided that the tests were to be carried out by an accredited body (rather than an individual, which was the case under the previous scheme).
	Regulation 8A provides that a body shall not be eligible for accreditation for the purposes of section 20 of the 1969 Act unless it is accredited to ISO/IEC/17025 by an accreditation body which complies with the requirements of ISO Guide 58 (now replaced by ISO 17011).
	The Regulations also deal with the procedures for taking bodily samples, despatch to a tester, testing and then reporting to the court. The Regulations require the completion of 2 statutory forms. Form 1 is called a "Direction Form" and is to be filled in by the court, the sampler and the tester. Form 2 is called "Report by Tester" and is to be filled in by the tester. All of this is designed to ensure that the right people actually provide samples, that the same samples reach the tester, and that the nominated tester does the testing and reports to the court.
	 Criteria for DCA accreditation prior to the recent review
	The ISO accreditation is a statutory requirement for "section 20" accreditation by the Department, as set out above. Bodies wishing to be added to the Department's accredited list were expected to produce evidence (either an original or a certified copy) of a valid and current ISO/IEC/17025 accreditation certificate, given by an accreditation body that complies with ISO/IEC Guide 58 (now ISO 17011).
	A further non-statutory requirement was added, as a matter of policy. This was a requirement to give an undertaking to comply with the Department of Health's  Code of Practice and Guidance on Genetic Paternity Testing Services. This Code sets out best practice and clear standards for organisations delivering paternity testing services generally.
	These criteria were put in place in 2001, when the Blood Tests (Evidence of Paternity) (Amendment) Regulations 2001 (SI 2001 No. 773) came into effect.
	More recent practice has been to require that written applications be made to be added to the DCA accredited list.
	The particular International Standards Organisation (ISO) standards were chosen because they were considered to be the most appropriate standards for this area of activity. ISO/IEC/17025 is an accreditation given to testing and calibration laboratories that meet certain competence requirements. There was no formal or public consultation on the criteria chosen for accreditation, but the 2001 Regulations, as a statutory instrument, had the approval of Parliament. The Department of Health's Code was put together by an ad-hoc advisory group on genetic paternity testing services, whose membership included service providers, clinicians, academics and scientists.
	 Ensuring compliance with ISO/IEC 17025 standards
	The accreditation bodies ensure compliance with ISO/IEC 17025 by undertaking regular reviews and re-accreditations. Because accreditation bodies are the technical experts, it is not necessary or appropriate for representatives of the Department themselves to visit any of the DCA-accredited laboratories, and no-one from the Department has ever done so. For the purposes of DCA accreditation, if an up to date and valid ISO 17025 certificate is produced (an original or certified copy) and the accreditation body is ISO Guide 58 (now ISIO 17011) compliant, then this is proof enough of the laboratory's competence.
	Bodies accredited by DCA are not permitted to contract out parentage tests directed by the court under s20 to any other organisation.
	 How the courts ensure accredited bodies carry out parentage tests where a section 20 direction is given
	Where the court is considering an application for a paternity test in the course of civil proceedings, and the parties do not agree to the testing, then section 20 of the 1969 Act is available. The court may give a formal direction (on Form 1, a statutory form, part of the Blood Tests (Evidence of Paternity) Regulations 1971 (as amended)) which will include the name and address of the body that is to carry out the test. The body will be chosen from the list of accredited bodies. The tester (a person employed to carry out scientific tests by an accredited laboratory) will complete and sign Form 2, (the Report by the Tester) to certify the result of the test. As explained above, the Regulations, which include the two statutory forms, are designed to ensure the authenticity and integrity of the samples, and that the nominated tester carries out and reports on the test.
	The list the Department maintains relates only to bodies which may carry out court-directed scientific tests for parentage in accordance with a direction made by a court pursuant to section 20 of the Family Law Act 1969. Where the court has not directed the test, parties to a case may submit DNA evidence by agreement and in accordance with case management directions of the court. It is not essential for the testing body to be chosen from the accredited list. As with other evidence, it is for the court to consider questions of admissibility and weight.
	 The investigation
	Starting in October last year, a number of Questions were tabled in Parliament and the Department received a number of press enquires about DNA Bioscience and the accredited list generally. This prompted an investigation as to the eligibility of each of the bodies on the accredited list, and the work also extended to a review of the processes and procedures associated with adding bodies to the list and the maintenance of it.
	The review did not extend to any examination of the financial accounts of the bodies on the DCA accredited list. DCA has no responsibility in this area. The bodies on the accredited list do not provide services to the Department. The accredited list simply exists to provide the civil courts with the names of bodies that reach a certain standard for use when the court directs a test under section 20 of the Family Law Reform Act 1969.
	The courts dealing with civil proceedings (including family proceedings) were informed about the review, and of the details of the laboratories to which referrals for court-directed tests should be made until the accredited list was re-issued. The laboratories concerned had provided the Department with up to date evidence they had the requisite ISO/IEC 17025 accreditation and with up to date undertakings that they complied with the Department of Health's Code.
	The Department undertook to remove ineligible bodies from the accredited list. There were six bodies that were found to be ineligible, including DNA Diagnostics Center and DNA Bioscience, three public sector laboratories (one of which no longer carries out paternity testing) and one body, not itself a testing body, which works in conjunction with another public sector laboratory. These bodies can no longer carry out section 20 tests and the civil courts have been informed. However, the Department has found no evidence that any individual or organisation has supplied misleading or incorrect information during the accreditation process and so further action taken against any individual or company would not be appropriate.
	 DNA Diagnostics Center and DNA Bioscience
	DNA Bioscience was not, itself, accredited by the DCA to carry out court-directed tests under s20. It was not a testing facility, so had no ISO 17025 accreditation and therefore was not eligible. Following an application from DNA Bioscience, DCA agreed in October 2005 that DNA Diagnostics Center (the laboratory DNA Bioscience used to conduct DNA tests) could be added to the accredited list. DNA Diagnostics Center is a US laboratory with ISO/IEC/17025 accreditation, accredited by Forensic Quality Services - a US accreditation body. DNA Diagnostics Center was shown on the accredited list with a Chelmsford address then belonging to DNA Bioscience. The Department was aware that DNA Bioscience was acting as an intermediary for DNA Diagnostics Center.
	The Department agreed orally in December 2004 that DNA Bioscience's details could be added to the accredited list, but DNA Bioscience did not make an application to be added to the accredited list on its own account. The intention was to add those details as a referral route to the accredited body (DNA Diagnostics Center).
	The Department is not aware of anything to suggest that reliable evidence was not produced for the courts in relation to court-directed tests.
	No DCA Minister, current or past, has had any communication, conversation, or correspondence with David Blunkett about DNA Bioscience.
	 Applications turned down and laboratories closed down
	From the Departmental records available, it appears that one application was received in 2003 from a laboratory that had no ISO 17025 accreditation. The laboratory in question indicated that they intended to apply for ISO 17025 accreditation, but nothing further was heard from them.
	Nothing has been found in the Department's records that are now available to indicate that any laboratory accredited by DCA to carry our court-directed parentage tests has closed down in the past five years.
	 Bodies currently accredited
	The following laboratories, all based in the UK, have submitted evidence of valid and up to date accreditation to the relevant ISO standard. They have recently given signed undertakings to comply with revised criteria (see "New criteria"). They were all bodies on the previous list.
	Cellmark Diagnostics (now Orchid Cellmark),
	Crucial Genetics,
	LGC Diagnostics, and
	The Forensic Science Service
	No laboratories outside the UK are currently accredited, but there is no statutory bar on the accreditation of overseas laboratories. The Department will continue to consider application from laboratories, wherever situated (see "New criteria" below).
	 New criteria and policy
	As a result of the review, the Department will now require applications to be made on a form prescribed by it, signed and submitted in hard copy.
	As before, bodies wishing to be added to the accredited list must have a current and valid ISO/IEC 17025 certificate that has been issued by an accreditation body which complies with ISO/IEC 17011 (formerly ISO Guide 58) An original certificate or a certified copy must be submitted with the application form. There is a new requirement that the accreditation body must also be a full member of the International Laboratory Accreditation Cooperation (ILAC). The Department considers that this is needed to demonstrate independent evidence of ISO/IES 17011 compliance. The United Kingdom Accreditation Service (UKAS) is the UK body that complies with this new requirement.
	Bodies wishing to be added to the accredited list must undertake to comply with the Code of Practice and Guidance on Genetic Paternity Testing Services, published by the Department of Health, or any revised version thereof.
	With regard to the Code, although the undertaking applies to parentage tests directed by the court pursuant to s20 of the Family Law Reform Act 1969, the Government strongly encourages providers of genetic paternity testing services to adhere to the Code for all tests. Applicants will be made aware of that view and will be informed that when section 45 of the Human Tissue Act comes into force later this year, it will be a criminal offence to take DNA, with the intention of having it tested, without consent.
	Bodies wishing to be added to the accredited list must undertake to comply, or ensure compliance with, the procedures as set out in the Blood Test (Evidence of Paternity) Regulations 1971 (SI 1971/1861) (as amended).
	Bodies wishing to be added to the accredited list must undertake to limit any statement regarding DCA accredited status on any promotional material, advertising, or web-site information to the following:
	"[Name of Organisation] has been accredited by the Department for Constitutional Affairs as a body that may carry out parentage tests directed by the civil courts in England and Wales under section 20 of the Family Law Reform Act 1969".
	Applicants will be advised that the Department regards phrases such as 'Government approved', 'Lord Chancellor approved' or 'DCA approved' as misleading and therefore not acceptable.
	All organisations on the DCA accredited list will be expected to be subject to an annual review to confirm eligibility, including compliance with the accreditation criteria to remain on the list. This will include giving renewed undertakings as set out above and ensuring compliance with any revised criteria.
	In future, the Department will not accept applications from intermediaries. The Department will continue to consider applications from laboratories outside the UK, but if any should meet the (revised) criteria and are added to the list, they will be shown with their overseas addresses and other contact details. If an overseas laboratory makes an application proposing to use an intermediary in the UK, the laboratory will be asked to explain how its proposed use of an intermediary would conform with the relevant legislation (The Blood Tests (Evidence of Paternity) Regulations 1971 (as amended)).
	This information and guidance will be published on the Department's web-site.
	 Applications pending
	The Department currently has seven applications or enquiries about how to apply which the Department will now pursue and consider against the revised list of criteria. A revised list will then be issued.